Pharmacovigilance & Regulatory Affairs Manager at DKT International

Job Purpose

• The Pharmacovigilance & Regulatory Affairs Manager is responsible for establishing, maintaining and overseeing a robust Pharmacovigilance (PV) system while leading all regulatory affairs activities for DKT Nigeria’s products portfolio.
• The role will ensure full compliance with NAFDAC Good Pharmacovigilance Practice (GPV)and regulatory requirements, while also driving product registration, lifecycle management, and new product development (NPD) initiatives.
• This position is critical to ensuring the safety, quality, and regulatory compliance of DKT Nigeria’s reproductive health portfolio, while supporting operations growth through timely approvals and expansion of new and existing products.

Key Responsibilities
Pharmacovigilance System Management:

• Establish, implement, and maintain a robust pharmacovigilance (PV) system in line with national regulatory requirements (e.g., NAFDAC) and global standards
• Ensure effective collection, documentation, and management of adverse drug reactions (ADRs)
• Oversee PV database management and ensure data integrity, completeness, and traceability
• Serve as the Pharmacovigilance Lead / Safety Officer for all products.

Regulatory Affairs & Product Registration:

• Lead product registration, renewal, and variation processes with regulatory authorities (e.g., NAFDAC)
• Prepare and submit regulatory dossiers in line with CTD/eCTD requirements
• Ensure timely approvals for all products (pharmaceuticals, medical devices, and related categories)
• Track regulatory timelines and proactively address submission gaps.

New Product Development (NPD):

• Provide regulatory and safety input into new product selection, evaluation, and introduction
• Lead regulatory due diligence for new products and market entry
• Ensure compliance requirements are met prior to product launch
• Support cross-functional teams (marketing, supply chain, programs) in product rollout.

SOPs, Compliance & Training:

• Develop, review, and update SOPs for pharmacovigilance and regulatory processes
• Ensure organization-wide compliance with internal policies and regulatory requirements
• Design and deliver training programs on PV, regulatory compliance, and reporting obligations
• Drive awareness and accountability for compliance across all departments.

Safety Reporting & Risk Management:

• Ensure timely detection, assessment, and reporting of safety cases in line with regulatory timelines
• Prepare and submit safety reports (e.g., PSURs, ICSRs) as required
• Identify, assess, and mitigate product-related risks
• Escalate critical safety issues and recommend risk minimization actions

Regulatory Liaison & Stakeholder Engagement:

• Serve as the primary point of contact with regulatory authorities and external stakeholders
• Manage relationships with regulatory agencies, partners, and healthcare providers
• Represent the organization in regulatory inspections, meetings, and industry forums
• Provide regulatory guidance to internal stakeholders for decision-making.

Quality, Audit & Continuous Improvement:

• Ensure compliance with applicable standards such as Good Pharmacovigilance Practice (GVP) and Good Manufacturing Practice (GMP)
• Lead internal audits and coordinate external regulatory inspections
• Identify gaps and implement corrective and preventive actions (CAPA)
• Drive continuous improvement in PV and regulatory systems, processes, and performance.

Key Performance Indicators (KPIs)

• Regulatory submissions approved within timeline
• Timeliness of ADR reporting (compliance with reporting timelines)
• Number of regulatory compliance issues or audit findings
• Pharmacovigilance system effectiveness (case reporting rate, completeness)
• On-time renewal of product registrations
• Training effectiveness and compliance adoption
• Data quality, system integrity, and compliance levels
• New product approval timelines and successful launches.

Qualifications & Experience

• Bachelor’s Degree in Pharmacy (Pharm.D preferred)
• 5 - 8 years’ experience in pharmacovigilance and/or regulatory affairs
• At least 3 years in a managerial or supervisory role
• Strong knowledge of national regulatory frameworks (e.g., NAFDAC)
• Experience with safety databases and regulatory submission systems
• Professional certification in pharmacovigilance or regulatory affairs is an advantage.

Skills & Competencies:

• Strong knowledge of drug safety and regulatory requirements
• Attention to detail and high level of accuracy
• Analytical and problem-solving skills
• Strong communication and stakeholder management
• Ability to work cross-functionally and manage multiple priorities.